C2 CryoBalloon FG-1017Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00854924006170), received between Nov 6, 2020 and Mar 20, 2024 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2024Unintended Ejection; Detachment of Device or Device Component; Unintended Ejection; Detachment of Device or Device Component

  ON 28-FEB-2024, PENTAX MEDICAL BECAME AWARE OF AN EVENT WHICH OCCURRED DURING USE IN ENGLAND WITHIN THE EMEA REGION INVOLVING FG-1017 CONTROLLER, SERIAL NUMBER (B)(6), LOT NUMBER 11232020-02; FG-1018 FOOT PEDAL, SERIAL NUMBER (B)(6), LOT NUMBER 1101-0067; AND CATHETER MODEL FG-1024, LOT NUMBER 04042023-03; AND CATHETER MODEL FG-1028, LOT NUMBER 07122023-01. PER THE INITIAL REPORT, THE PATIENT WAS UNDERGOING A CRYOBALLOON ABLATION PROCEDURE AND THE USER CLAIMS EXTENSIVE KNOWLEDGE OF THIS SYSTEM. THE USER STATED THE PRODUCT WAS CORRECTLY SET UP BY THE NURSING TEAM, A STANDARD FOCAL CATHETER WAS INSERTED, AND WHEN THE TEST PUFF WAS INITIATED, THE BALLOON INFLATED AND A LOW BALLOON PRESSURE WAS DETECTED BY THE CONTROLLER. THIS PROMPTED THE USER TO REPLACE THE NITROUS OXIDE CARTRIDGE. WHEN THE USER UNSCREWED THE CONTROLLER CAP THE CAP FLEW OFF AND HIT THE CEILING. THE USER MENTIONED THE PRESSURE WAS TOO HIGH. THE PROCEDURE CARRIED ON WITH A CHANGED CARTRIDGE. THE PHYSICIAN DECIDED TO CHANGE TO A PEAR CATHETER DUE TO ABLATION AT THE GASTROESOPHAGEAL JUNCTION (GEJ). THE PROCEDURE WAS COMPLETED, AND THE NURSE FOLLOWED THE INSTRUCTIONS FOR REMOVAL OF THE CAP AND AGAIN WHILE UNSCREWING THE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943024 ↗
• InjuryOct 18, 2023Unintended Movement; Firing Problem; Unintended Movement; Firing Problem

  REFER TO H10.

  Patient problems: Pain

  MAUDE report 17959805 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PENTAX MEDICAL WAS MADE AWARE OF AN ADVERSE EVENT ON (B)(6) 2022 THAT OCCURRED AT (B)(6) IN THE ENDOSCOPY SUITE WHILE USING A PENTAX MEDICAL C2 CRYOBALLOON CONTROLLER MODEL FG-1017, SERIAL NUMBER (B)(4), AND FOCAL STANDARD CATHETER MODEL FG-1028, LOT NUMBER 03162022-01. THE INITIAL REPORT WAS OF AN ADVERSE EVENT RESULTING IN A 9 INCH ESOPHAGEAL TEAR. THE NINE INCH TEAR WAS IMMEDIATELY TREATED WITH ELEVEN ENDOSCOPIC CLIPS IN THE ENDOSCOPY SUITE BY THE PHYSICIAN. ADDITIONAL INFORMATION RECEIVED ON 20-OCT-2022, THE PHYSICIAN STATED THEY EXPERIENCED A WEIRD COMPLICATION TODAY FROM CRYOBALLOON TREATMENT IN A PATIENT WITH BARRETT'S ESOPHAGUS. THE PATIENT HAD NO PRIOR TREATMENTS, SUCH AS EMR(ENDOSCOPIC MUCOSAL RESECTION), RFA(RADIOFREQUENCY ABLATION), RADIATION, ETC. THE PROCEDURE WAS INITIATED BY PLACING THE BALLOON AT THE PROXIMAL HALF OF THE LONG BE(BARRETT'S ESOPHAGUS), ABOVE 35 CM, GEJ(GASTROESOPHAGEAL JUNCTION) AT 40CM. CRYOGEN DOSE WAS SET AT 8 SECONDS.THE BALLON WAS INFLATED AND THEN JUST AFTER THE FIRST PRE-PUFF, THE USERS NOTICED A LONG LINEAR DEEP TEAR WITH FRESH BLOOD. WE REMOVED THE BALLOON AND INSPECTED THE ESOPHAGUS. THERE WAS A DEEP MUCOSAL TEAR, BUT NO PERFORATION, AT THE

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 15795011 ↗
• InjuryMay 11, 2022Premature Activation; Premature Activation

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2022 THAT OCCURRED IN THE OPERATING ROOM DURING USE IN THE UNITED STATES. PER THE INITIAL CUSTOMER REPORT, THE PHYSICIAN ADVANCED THE BALLOON INTO A PATIENT'S ESOPHAGUS, AND AUTOMATICALLY INFLATED BALLOON WITH THE FOOT PEDAL, WHICH RESULTED IN A PERFORATION OF THE ESOPHAGUS, INVOLVING PENTAX MEDICAL C2 CRYOBALLOON ABLATION SYSTEM, FOCAL STANDARD CATHETER MODEL FG-1028, USED WITH CRYOBALLOON CONTROLLER MODEL FG-1017 AND CRYOBALLOON FOOT PEDAL MODEL FG-1018. LOT AND SERIAL NUMBERS ARE UNKNOWN FOR ALL PRODUCTS. THE PATIENT WAS SENT TO SURGERY AND UNDERWENT ESOPHAGECTOMY AND REPAIR OF THE PERFORATION. THE PATIENT DID WELL AND WAS DISCHARGED HOME. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Perforation of Esophagus

  MAUDE report 14361674 ↗
• MalfunctionMar 31, 2022Gas Output Problem; Gas Output Problem

  IT WAS REPORTED THAT THE FG-1017- CRYOBALLOON CONTROLLER WAS MALFUNCTIONING. THE PHYSICIAN WAS REPORTEDLY PREPARING TO PERFORM A CRYOBALLOON ABLATION, WHEN ON HIS INITIAL INFLATION ATTEMPT A PUFF WAS HEARD IN THE CONTROLLER, THE BALLOON WOULD NOT INFLATE AND FAULT SCREEN APPEARED ASKING IF THE CATHETER WAS PROPERLY ATTACHED. THEY TRIED TO TROUBLE SHOOT THIS, BUT THE ISSUE WOULD NOT GO AWAY. THEY TRIED MULTIPLE CATHETERS AND CARTRIDGES AND COULD NOT RESOLVE THE PROBLEM. THE PHYSICIAN MOVED TO TREAT THE PATIENT WITH ALTERNATIVE THERAPY OPTIONS AND ALERTED THE PENTAX MEDICAL SALES REP TO THE ISSUE. NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER, OR DELAY IN THE PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION WAS REPORTED BY THE USER. ONCE RETURNED, THE CONTROLLER WILL BE EVALUATED AS PART OF THE INVESTIGATION. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13969405 ↗
• MalfunctionMar 31, 2022Gas Output Problem; Gas Output Problem

  ON 18-FEB-2022, PENTAX MEDICAL WAS MADE AWARE OF A REPORT THAT AN FG-1017- CRYOBALLOON CONTROLLER HAD A MALFUNCTION WHERE ON INITIAL INSERTION OF NITROUS OXIDE CARTRIDGE, GAS BEGAN TO SLOWLY LEAK THROUGH CONTROLLER BODY FROM FRONT AND REAR EXHAUST PORTS PREVENTING THE BALLOON FROM BEING ABLE TO ABLATE. THE CASE WAS CANCELLED. INITIALLY THIS WAS DETERMINED TO BE A NON-REPORTABLE EVENT AS THERE WAS NO REPORT OF INJURY TO THE PATIENT OR USER. IF THIS MALFUNCTION WERE TO RECUR, THE CONTROLLER IS DESIGNED TO CONTAIN NITROUS OXIDE AND VENT SLOWLY, THEREFORE POSED NO RISK TO PATIENT OR USER. THERE WAS ALSO A REVIEW OF THE CURRENT COMPLAINT DATA THAT SHOWED THAT THERE HAD BEEN NO ADVERSE EVENTS ASSOCIATED WITH NITROUS OXIDE VENTING FROM THE CARTRIDGE ON THIS DEVICE OR ANY SIMILARLY MARKETED DEVICE IN THE PAST 36 MONTHS. A VOLUNTARY REPORT FORM MW5107665 WAS RECEIVED FROM THE FDA VIA MAIL ON 18-MAR-2022. THE EVENT DESCRIPTION FROM THE VOLUNTARY REPORT MATCHED THE EVENTS DOCUMENTED WITHIN THIS COMPLAINT, AN OUT OF BOX FAILURE DUE TO A NITROUS OXIDE LEAK WITHIN THE CONTROLLER BODY AND AS A RESULT THE BALLOON DID NOT FILL AS DESIGNED. ALTHOUGH THE "CONTROLLER LEAK ISSUE INVESTIGATION" IDENTIFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13969308 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 15-JAN-2021 THAT OCCURRED IN THE ENDOSCOPY SUITE DURING USE IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THE "BALLOON WAS INFLATED IN THE ESOPHAGUS, RESULTING IN A MUCOSAL TEAR (NOT PERFORATION).", INVOLVING PENTAX MEDICAL C2 CRYOBALLOON CONTROLLER, MODEL FG-1017, SERIAL NUMBER (B)(4), AND PENTAX MEDICAL C2 CRYOBALLOON STANDARD FOCAL CATHETER, MODEL FG-1028, UNKNOWN LOT NUMBER. THE PHYSICIAN DEPLOYED THREE MUCOSAL CLIPS TO ADDRESS THE TEAR AND PROCEEDED TO TREAT THE BARRETT'S DISEASE PROXIMAL TO THE CLIPPED AREA WITH THE STANDARD FOCAL CATHETER. THE PROXIMAL TREATMENT WAS COMPLETED AS PLANNED. THE PATIENT RETURNED APPROXIMATELY 8 WEEKS LATER FOR A SCHEDULED FOLLOW-UP VISIT TO ASSESS HIS/HER ESOPHAGUS FOR BARRETT'S DISEASE. THE PATIENT REPORTED SIGNIFICANT PAIN FOR 6 WEEKS FOLLOWING THE (B)(6) 2021 PROCEDURE AND THE PHYSICIAN DECIDED TO NOT PROCEED WITH FURTHER CRYOBALLOON THERAPY WITH THIS PATIENT. ON (B)(6) 2021, A LOT HISTORY RECORD(LHR) REVIEW FOR PENTAX MEDICAL C2 CRYOBALLOON CONTROLLER, MODEL FG-1017, SERIAL NUMBER (B)(4) WAS PERFORMED. THE LHR REVIEW CONFIRMED THE CONTROLLER WAS MANUFACTURED ON NOVEMBER 13, 2020 AND RELEASE

  Patient problems: Laceration(s); Pain

  MAUDE report 11787602 ↗
• InjuryApr 21, 2021Failure to Deflate; Failure to Deflate

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE ENDOSCOPY SUITE DURING USE IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THE PHYSICIAN REPORTS THAT "THE BALLOON INFLATED PRIOR TO HER PRESSING THE INFLATE PEDAL. SHE WAS NOT ABLE TO DEFLATE THE BALLOON WITH SEVERAL ATTEMPTS AND TRIED MANUAL DEFLATION. THERE WERE LACERATIONS WHEN THE BALLOON WAS DEFLATED AND CLIPS WERE PLACED. NO ABLATION WAS PERFORMED", INVOLVING PENTAX MEDICAL C2 CRYOBALLOON GOLF CONTROLLER, MODEL FG-1017, SERIAL NUMBER (B)(4), LOT NUMBER 07202020-01, AND PENTAX MEDICAL C2 CRYOBALLOON STANDARD FOCAL CATHETER, MODEL FG-1028, LOT NUMBER 09082020-01. PENTAX SALES REP WAS ONSITE AT (B)(6) ON 21-APR-2021 AND OBTAINED ADDITIONAL CASE DETAILS. THE INITIAL PROCEDURE DATE WAS CONFIRMED AS (B)(6) 2021 AND THE PATIENT WAS A (B)(6) YEAR OLD MALE PATIENT. THE REPORTED PERFORATION WAS LOCATED AT THE D4 DUODENUM AREA. THE REPORTED PERFORATION RESULTED IN A PROLONGED HOSPITAL STAY FOR THE PATIENT. THE PATIENT HAS NOT BEEN RECALLED FOR FURTHER SCREENING BUT IS RECOVERING AND WILL BE SCREENED FURTHER. ON 21-APR-2021, A LOT HISTORY RECORD(LHR) REVIEW FOR MODEL FG-1017, SERIAL NUMBER (B)(4), LOT NUMBER 07202020-01

  Patient problems: Laceration(s)

  MAUDE report 11703186 ↗
• InjuryNov 6, 2020Gas Output Problem; Gas Output Problem

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE OPERATING ROOM DURING USE IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THE PHYSICIAN HAD PRESSED AND RELEASED THE NITROUS OXIDE DELIVERY SWITCH, BUT THE PRODUCT CONTINUED TO DELIVER NITROUS OXIDE UNTIL THE END OF A FULL TREATMENT CYCLE. THE CONTROLLER DISPLAYED A NON-STANDARD SCREEN. THE SCREEN WAS NON-RESPONSIVE, AND THE CONTROLLER MADE A CONTINUOUS TONE UNTIL THE POWER/COMMUNICATION CORD FOR THE CONTROLLER WAS DISCONNECTED AND RECONNECTED, INVOLVING PENTAX MEDICAL C2 CRYO-BALLOON GOLF CONTROLLER, MODEL: FG-1017, LOT NUMBER 0243. AT THE TIME OF REPORTING, THE PENTAX MEDICAL DIRECTOR OF ENGINEERING FOR C2 PRODUCTS DOCUMENTED THAT A SERIOUS INJURY OCCURRED, BUT NO ADDITIONAL DETAIL WAS PROVIDED AT THE TIME. THE PENTAX MEDICAL DIRECTOR OF ENGINEERING FOR C2 PRODUCTS RESPONDED TO A GOOD FAITH EFFORT REQUEST FOR ADDITIONAL INFORMATION VIA EMAIL ON 22-OCT-2020, AND STATED THE CRYO-BALLOON ABLATION SYSTEM WAS BEING USED FOR PATIENT TREATMENT. THE SERIOUS INJURY WAS A SINGLE UNINTENDED TREATMENT OF TISSUE, ALTHOUGH NO PATIENT HARM WAS NOTED. THIS MOMENTARY DELAY RESULTING IN A FEW SECONDS OF EXTRA ANESTHESIA. THE PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10805342 ↗