C2 CryoBalloon FG-1028Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00854924006286), received between Apr 21, 2021 and Nov 14, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Deflate” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 15795050 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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, A PERFORATION OCCURRED IN A PATIENT WITH SQUAMOUS CANCER INVOLVING UNKNOWN MODEL AND SERIAL/LOT NUMBERS. 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 15493705 ↗
• 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 14361748 ↗
• MalfunctionNov 19, 2021Pressure Problem; Pressure Problem

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE UNITED STATES DURING A GEN 2 CRYOBALLOON PROCEDURE. THE CUSTOMER REPORTED THAT WHILE BEING USED WITH THE CRYOBALLOON CONTROLLER SYSTEM IT BEGAN TO BEHAVE ABNORMALLY WITH A LOW BALLOON PRESSURE FAULT MESSAGE, BUT THE NITROUS WOULD CONTINUE TO FLOW INVOLVING GEN 2 FOCAL STANDARD CATHETER MODEL FG-1028. THERE WAS NO REPORT OF PATIENT INJURY, AND THE DOCTOR SUCCESSFULLY ABLATED THE AREA OF CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12845064 ↗
• 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 (B)(6) 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)

  MAUDE report 11787581 ↗
• 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 (B)(6) 2021 AND OBTAINED ADDITIONAL CASE DETAILS. THE INITIAL PROCEDURE DATE WAS CONFIRMED AS (B)(6) 2021 AND THE PATIENT WAS A (B)(6) 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 (B)(6) 2021, A LOT HISTORY RECORD(LHR) REVIEW FOR MODEL FG-1017, SERIAL NUMBER (B)(4), LOT NUMBER 07202020-01 WAS PERF

  Patient problems: Laceration(s)

  MAUDE report 11703223 ↗