C2 CryoBalloon Focal Controller FG-1012Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00854924006125), received between Dec 20, 2016 and Mar 24, 2021 — classified as 9 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 9 most recent of 9 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 11562032 ↗
• InjurySep 2, 2020Material Split, Cut or Torn

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT ON 03-AUG-2020 THAT OCCURRED IN AN OPERATING ROOM DURING A PROCEDURE IN THE UNITED STATES. SUSPECTED DEVICE MALFUNCTION OF PENTAX/C2 CRYOBALLOON PROCEDURE ON (B)(6) 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 CRYOBALLOON FOCAL ABLATION HANDLE/CONTROLLER, MODEL FG-1012, USED WITH A PENTAX MEDICAL C2 CRYOBALLOON 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 DEFLAT

  Patient problems: Laceration(s)

  MAUDE report 10485979 ↗
• InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  C2 THERAPEUTICS BECAME AWARE OF A SERIOUS ADVERSE EVENT ON (B)(6) 2017. - PATIENT HAS A HISTORY OF PRIMARY LUNG CANCER WITH AGGRESSIVE CHEMO RADIATION TREATMENT. - SUCCESSFUL CRYOBALLOON TREATMENT FOR SQUAMOUS CELL CARCINOMA IN (B)(6) 2017. - ON (B)(6) 2017 AN EMR WAS DONE TO REMOVE RESIDUAL SQUAMOUS CA. - ON (B)(6) 2017 SQUAMOUS CA WAS TREATED WITH CRYOBALLOON FOR RESIDUAL CA. CRYOBALLOON PRODUCT PERFORMED AS REQUIRED. - PERFORATION WAS NOTICED IN THE DISTAL ESOPHAGUS UPON REMOVAL OF THE CRYOBALLOON FROM THE SCOPE. - ON (B)(6) 2017 AT 3:30 PM THE PATIENT WAS DOING FINE. X-RAYS WERE NEGATIVE FOR FREE AIR. BARIUM SWALLOW TEST WILL BE PERFORMED TO EVALUATE STENT EFFECTIVENESS.

  Patient problems: Perforation of Esophagus

  MAUDE report 7051278 ↗
• InjuryOct 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  C2 THERAPEUTICS BECAME AWARE OF A STRICTURE EVENT ON (B)(4) 2017. THE PATIENT WAS INITIALLY TREATED WITH THE CRYOBALLOON ABLATION SYSTEM ON (B)(6) 2017. DURING A FOLLOW-UP ENDOSCOPY EXAMINATION ON (B)(6) 2017, A MILD BENIGN APPEARING, INTRINSIC STENOSIS WAS OBSERVED. PATIENT WAS DILATED AND THE SITE WAS EXAMINED AND SHOWED COMPLETE RESOLUTION OF THE STRICTURE. FINAL RESULT: RESOLVED WITHOUT SEQUELAE.

  Patient problems: Stenosis

  MAUDE report 6970211 ↗
• InjuryOct 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  C2 THERAPEUTICS BECAME AWARE OF STRICTURE EVENT ON (B)(6) 2017. PATIENT WAS TREATED WITH THE CRYOBALLOON ABLATION SYSTEM ON (B)(6) 2017. ON (B)(6) 2017 PATIENT EXPERIENCED DYSPHAGIA. ON (B)(6) 2017 PATIENT NOTIFIED NURSE PRACTITIONER OF THE DYSPHAGIA AND A STRICTURE WAS NOTICED UPON EXAMINATION. ON (B)(6) 2017 PATIENT HAD STRICTURE DILATED.

  Patient problems: Dysphagia/ Odynophagia; Stenosis

  MAUDE report 6959838 ↗
• InjuryOct 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  C2 THERAPEUTICS BECAME AWARE OF AN EVENT ON (B)(6) 2017 A COMMERCIAL PATIENT WITH HGD EXPERIENCED BRADYCARDIA DURING A CRYOBALLOON PROCEDURE. THERE WERE 8 ABLATIONS PERFORMED WITH THE CRYOBALLOON SYSTEM. THE PATIENT WAS BRADYCARDIC INTO THE 20-30S, THE PATIENT WAS THEN GIVEN ATROPINE WHICH RESOLVED THE BRADYCARDIA. THE PATIENT'S HEMODYNAMICS STABILIZED AND HE WOKE UP FROM ANESTHESIA WITHOUT COMPLICATIONS. THE PATIENT WENT HOME ON THE SAME DAY AS SCHEDULED.

  Patient problems: Bradycardia

  MAUDE report 6953223 ↗
• InjurySep 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  C2 BECAME AWARE OF DYSPHAGIA EVENT ON (B)(6) 2017. THE PATIENT WAS INITIALLY TREATED WITH THE CRYOBALLOON ON (B)(6) 2017. AT A 30-DAY PHONE CALL FOLLOW UP, THE PATIENT REPORTED DIFFICULTY SWALLOWING AND FOOD GETTING STUCK IN THE ESOPHAGUS (ON (B)(6) 2017), BUT EVENTUALLY WENT DOWN. THE PATIENT WAS SCHEDULED FOR EGD ON (B)(6) 2017 WITH A POSSIBLE DILATION TO ADDRESS THE DYSPHAGIA. A NARROWED AREA IN THE ESOPHAGUS WAS NOTED; THE ENDOSCOPE WAS PASSED THROUGH THE AREA OF NARROWING AND NO FURTHER DILATION WAS PERFORMED.

  Patient problems: Dysphagia/ Odynophagia; Stenosis

  MAUDE report 6904987 ↗
• InjuryAug 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS A (B)(6) FEMALE WITH A HISTORY OF SQUAMOUS CELL CANCER OF THE ESOPHAGUS AND LUNG CANCER. THE PATIENT HAD PREVIOUS RADIATION TREATMENT, A PREVIOUS ENDOSCOPIC MUCOSAL RESECTION (EMR) IN THE MID ESOPHAGUS AS WELL AS TWO PREVIOUS CRYOBALLOON ABLATION TREATMENTS. PATIENT UNDERWENT CRYOABLATION PROCEDURE WITH THE C2 CRYOBALLOON ABLATION SYSTEM ON (B)(6) 2017. THE PHYSICIAN SPRAYED LUGOL'S SOLUTION DILUTED TO 2% TO IDENTIFY THE LESIONS; ONCE IDENTIFIED HE USED A SNARE TIP TO COAGULATE MARK THE SITES HE WAS GOING TO ABLATE. THE FIRST ABLATION WAS SUCCESSFUL, BUT AT THE SECOND ABLATION SITE (THE MORE PROXIMAL LESION) THE PHYSICIAN NOTICED A PERFORATION THAT WAS 8 CM LONG BY 5 MM WIDE. THE PHYSICIAN SUCCESSFULLY PLACED AN ESOPHAGEAL STENT THEN SUTURED TO PREVENT MIGRATION. AFTER CHECKING WITH THE PATIENT IN RECOVERY THE PHYSICIAN NOTED THAT THE PATIENT WAS DOING FINE AND NOT IN ANY PAIN. ON (B)(6) 2017 DURING A CONVERSATION BETWEEN C2 THERAPEUTICS AND THE PHYSICIAN, THE PHYSICIAN NOTED THAT HE WAS SURPRISED AT HOW FRAGILE THE ESOPHAGUS WAS BUT HE WAS NOT DISCOURAGED. HE DESCRIBED THE PATIENT AS BEING VERY SICK WITH AN EXTENSIVE HISTORY OF TREATMENT INCLUDING THE 2 PREVIOUS CRY

  Patient problems: Perforation of Esophagus

  MAUDE report 6804215 ↗
• InjuryDec 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE ABLATION PROCEDURE ON (B)(6) 2016, 6 ABLATIONS OF 10 SECONDS EACH WERE COMPLETED SUCCESSFULLY. ON ABLATION 7, THE BALLOON DEFLATED PREMATURELY AFTER 2 TO 3 SECONDS (2 ATTEMPTS). THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2016 DURING TELEPHONE FOLLOW-UP, THE PATIENT REPORTED DIFFICULTY SWALLOWING. THE PATIENT WAS NOT HOSPITALIZED, BUT HIS MEDICATION AND DIET WERE CHANGED. ON (B)(6) 2016, THE PATIENT WAS ABLE TO EAT SOFT FOOD BUT WAS STILL HAVING DIFFICULTY SWALLOWING. THE PHYSICIAN DETERMINED THAT THIS ADVERSE EVENT IS MILD IN ITS INTENSITY AND IS PROCEDURE RELATED, NOT DEVICE RELATED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 6190364 ↗