C2 CryoBalloon FG-1018Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00854924006187), received between May 11, 2022 and Oct 18, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Firing Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2023Unintended Movement; Firing Problem; Unintended Movement; Firing Problem

  PENTAX MEDICAL BECAME AWARE OF AN EVENT WHICH OCCURRED DURING A CLINICAL STUDY (PROTOCOL CP-0019 REV B) IN THE NETHERLANDS INVOLVING CRYOBALLOON ABLATION SYSTEM CONTROLLER MODEL FG-1017, FOOT PEDAL MODEL FG-1018, AND CATHETER MODEL FG-1056. CATHETER MODEL FG-1056 IS AN INVESTIGATIONAL CATHETER ESPECIALLY MANUFACTURED FOR THIS STUDY AND IS NOT AVAILABLE COMMERCIALLY. PER THE INITIAL REPORT, THE FIRST 180 DEGREE TREATMENT DURING THE PROCEDURE WENT AS INTENDED BY THE CLINICAL STUDY RESEARCH PHYSICIAN. THE PHYSICIAN PROCEEDED TO THE NEXT STEP OF THE PROCEDURE TO TREAT AN ADDITIONAL AREA OF THE ESOPHAGUS. THE PHYSICIAN USED THE FOOT PEDAL TO ROTATE THE DIFFUSER LOCATED WITHIN THE CATHETER BALLOON TO PLACE THE DIFFUSER IN POSITION TO TREAT THE NEXT SEGMENT OF UNWANTED TISSUE OF THE ESOPHAGUS. WHEN THE PHYSICIAN STOPPED PRESSING THE FOOT PEDAL, THE DIFFUSER CONTINUED TO ROTATE BEYOND THE INTENDED STOPPING POSITION. AT THIS POINT IN THE PROCEDURE, THE ENDOSCOPIST INTENDED TO USE THE FOOT PEDAL TO PRODUCE A SHORT BURST OF CRYO-TREATMENT (CALLED A PRE-PUFF) TO EVALUATE THE EXACT POSITION OF THE DIFFUSER IN THE ESOPHAGUS. THE ACTUAL PRE-PUFF WAS NOT AN EXPECTED SHORT BURST OF CRYO-TREATMENT;

  Patient problems: Pain

  MAUDE report 17959806 ↗
• 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 14361568 ↗