C2 CryoBalloon Focal Catheter, Standard FG-1009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00854924006095), received between Feb 27, 2017 and Mar 24, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2021 THAT OCCURRED DURING USE IN THE UNITED STATES. THE REPORTED COMPLAINT WAS THAT THE SYSTEM PREPARATION AND BALLOON PLACEMENT PROCEEDED NORMALLY. IMMEDIATELY UPON INITIAL PUFF INFLATION OF THE BALLOON, A LARGE LACERATION AND BLEEDING WAS OBSERVED, AND THE BALLOON WAS REMOVED AND THE THERAPY WAS STOPPED. THE PROCEDURE INVOLVED PENTAX MEDICAL C2 CRYOBALLOON GOLF CONTROLLER, MODEL FG-1012, LOT NUMBER 02012021-01, AND CRYOBALLOON FOCAL ABLATION CATHETER MODEL FG-1009, LOT NUMBER 07092020-02. THE PHYSICIAN SPENT A GOOD AMOUNT OF TIME INSPECTING THE LACERATION AND CONCLUDED THAT IT WAS ONLY TO THE MUSCLE LAYER, NOT A FULL PERFORATION. THE PHYSICIAN DID NOT CLIP OR OTHERWISE TREAT THE LACERATION, JUST ENSURED THE BLEEDING STOPPED AND LEFT IT TO HEAL ON ITS OWN. BASED ON INPUT FROM THE PENTAX SALES REPRESENTATIVE IN THE PROCEDURE ROOM, THE SYSTEM DID NOT APPEAR TO HAVE MALFUNCTIONED, AND NO SYSTEM FAULTS WERE NOTED DURING THE PROCEDURE. THE PHYSICIAN CONCLUDED THAT WHATEVER IT WAS THAT WAS CAUSING THIS PATIENTS MUCOSA TO PRESENT BARRETT'S IN THIS UNIQUE WAY AND ALLOW FOR THE EASY DENUDING OF THE MUCOSA WITH RADIOFREQUENCY ABLATION (

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s) of Esophagus

  MAUDE report 11562027 ↗
• InjurySep 2, 2020Burst Container or Vessel; Burst Container or Vessel

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT ON (B)(6) 2020 THAT OCCURRED IN AN OPERATING ROOM DURING A PROCEDURE IN THE UNITED STATES. SUSPECTED DEVICE MALFUNCTION OF PENTAX/C2 CRYO BALLOON PROCEDURE ON SWEDISH HOSPITAL PATIENT (B)(6) 2020. THE PHYSICIAN REPORTED THE INCIDENT TO THE (B)(6) RISK MANAGER ON (B) (6) 2020. HE REPORTED, "THAT OVER INFLATION OF THE BALLOON CAUSED THE TEAR IN THE ESOPHAGUS," INVOLVING PENTAX MEDICAL C2 CRYO BALLOON FOCAL ABLATION HANDLE/CONTROLLER, MODEL FG-1012, USED WITH A PENTAX MEDICAL C2 CRYO BALLOON FOCAL ABLATION CATHETER, MODEL FG-1009. THE DECISION WAS MADE TO ABLATE WITH NITROUS OXIDE BALLOON CRYOTHERAPY. ENDOSCOPIC VISUALIZATION IDENTIFIED AN ABLATION SITE FROM 35-40 CM WAS IDENTIFIED. THE CATHETER WAS INSERTED INTO THE WORKING CHANNEL, AND THE TIP VISUALLY PLACED INTO THE STOMACH. A SINGLE PUFF OF NITROUS OXIDE WAS USED TO INFLATE THE BALLOON WITH EXCELLENT VISUALIZATION. WE ATTEMPTED TO TREAT THE AREA SELECTED, BUT THE DEVICE DID NOT RELEASE ANY NITROUS OXIDE. THE BALLOON WAS DEFLATED AND A DIFFERENT CARTRIDGE INSERTED. THE DEVICE HANDLE WAS RESET AND THE SINGLE PUFF USED TO RE INFLATE THE BALLOON. AN ATTEMPT AT TREATMENT FAILED. AS THE BALLOON

  Patient problems: Laceration(s)

  MAUDE report 10486038 ↗
• InjuryFeb 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE (B)(6) 2016 PROCEDURE, 11 ABLATIONS WERE PERFORMED. THE PATIENT REPORTED A PAIN SCORE OF 4 (1 TO 10 SCALE) ON DAY 1 AND 0 ON DAY 7. ON (B)(6) 2017, THE PATIENT CAME TO THE EMERGENCY ROOM WITH DIFFICULTY SWALLOWING FOR 3 DAYS. AN ENDOSCOPY WAS PERFORMED AND SHOWED A BENIGN APPEARING ESOPHAGEAL STENOSIS THAT WAS DILATED. THE PATIENT'S SYMPTOMS IMPROVED, BUT HE WAS UNABLE TO CONSUME A NORMAL DIET THROUGH 4 DAYS POST DILATION. AN ENDOSCOPY WAS PERFORMED ON (B)(6) 2017. THERE WAS A SEVERE BENIGN STENOSIS. THE STRICTURE HAD A 6 MM DIAMETER AND 1 CM LENGTH. COAGULATION FOR TISSUE DESTRUCTION USING A MONOPOLAR PROBE (IT2 KNIFE) WAS PERFORMED. DILATION WITH A 15-16.5-18 MM X 5.5 CM CRE BALLOON DILATOR WAS PERFORMED TO 16 MM, AND THE AREA WAS INJECTED WITH 80 MG OF TRIAMCINOLONE (40 MG/ML, DILUTED UP TO 5 ML). THE STOMACH AND DUODENUM WERE NORMAL. THE PATIENT IS SCHEDULED FOR REPEAT UPPER ENDOSCOPY IN 1 MONTH FOR RETREATMENT. THE PHYSICIAN STATED THAT, "THE STRICTURES WILL OCCUR AFTER ANY MUCOSAL ABLATING THERAPY, THIS EVENT IS NOT LIFE-THREATENING AND AS SUCH I WOULD LIKE TO WAIT AND SEE THE COMPLETE UPDATE IN 2 WEEKS."

  Patient problems: Stenosis

  MAUDE report 6361363 ↗