BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2 CRYOBALLOON FOCAL ABLATION SYSTEM

    MDR report key: 6257455 · Received January 17, 2017

    Report

    Report Number
    3008780134-2017-00001
    Event Type
    Injury
    Date Received
    January 17, 2017
    Date of Event
    April 3, 2017
    Report Date
    April 4, 2017
    Manufacturer
    C2 THERAPEUTICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K161202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS FOLLOW-UP REPORT FOR THE MDR REFERENCE: (B)(4). A COMMERCIAL PATIENT WAS ORIGINALLY TREATED ON (B)(6) 2016. THE PHYSICIAN PLANNED A FOLLOW UP CRYOBALLOON PROCEDURE ON (B)(6) 2017. DURING THE FOLLOW UP ON (B)(6) 2017 THERE WAS A STRICTURE NOTICED; THE PATIENT WAS DILATED. THE PATIENT WAS ALSO TREATED WITH THE CRYOBALLOON THE SAME DAY IN ANOTHER AREA. NO ISSUE WITH THIS PROCEDURE WAS RECORDED. STRICTURE REQUIRING TREATMENT IS AN ANTICIPATED ADVERSE EVENT AFTER ENDOSCOPE ABLATION THERAPY. THEREFORE, THIS STRICTURE REQUIRING TREATMENT IS LIKELY RELATED TO THE PROCEDURE. PATIENT RESPONDED WELL TO TREATMENT OF STRICTURE. NO REPORT OF COMPLICATIONS OR SEQUELAE. PER REQUEST FROM FDA ON 26MAR2020, SUPPLEMENTAL REPORT WAS SUBMITTED WITH INCORRECT REPORT NUMBER. THIS REPORT IS BEING SUBMITTED TO CORRECT THE REPORT NUMBER FROM 3008780143-2017-00006 TO 3008780134-2017-0001 FOLLOW UP #1 NOTE: THE FOLLOWING CODES ON PREVIOUS FOLLOW-UP NO LONGER AVAILABLE. 3263-ACTUAL DEVICE NOT EVALUATED. 3332-QUALITY CONTROL REVIEW. 3372-ANALYSIS OF DATA LOG(S).

    Description of Event or Problem · 0

    THE FOLLOW-UP REPORT FOR THE MDR REFERENCE: (B)(4). A COMMERCIAL PATIENT WAS ORIGINALLY TREATED ON (B)(6) 2016. THE PHYSICIAN PLANNED A FOLLOW UP CRYOBALLOON PROCEDURE ON (B)(6) 2017. DURING THE FOLLOW UP ON (B)(6) 2017 THERE WAS A STRICTURE NOTICED; THE PATIENT WAS DILATED. THE PATIENT WAS ALSO TREATED WITH THE CRYOBALLOON THE SAME DAY IN ANOTHER AREA. NO ISSUE WITH THIS PROCEDURE WAS RECORDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, AND FURTHER INVESTIGATION COULD NOT BE CONDUCTED. THERE WERE NO PERFORMANCE ISSUES IDENTIFIED FOR THE DEVICE DURING THE PROCEDURE. THE EVENT APPEARS TO BE UNRELATED TO THE DEVICE PERFORMANCE.

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED WITH CRYOABLATION ON (B)(6) USING THE C2 CRYOBALLOON FOCAL ABLATION SYSTEM. HE HAD LONG SEGMENT HIGH GRADE DYSPLASIA, AND THE DOCTOR PERFORMED 26 ABLATIONS. THE POST PROCEDURE PAIN SCORE WAS 10, AND HE WAS ALREADY ON NARCOTICS FOR A PREVIOUS CONDITION. DURING THE HOLIDAYS, THE PATIENT WENT TO HIS LOCAL EMERGENCY DEPARTMENT COMPLAINING OF PAIN AND DIFFICULTY SWALLOWING BUT WAS NOT SCOPED. HE ALSO HAD ABDOMINAL ISSUES THAT MAY HAVE BEEN PRE-EXISTING. THE PATIENT IS ON A PUREED DIET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41149 C2 CRYOBALLOON FOCAL ABLATION SYSTEM CRYOSURGICAL UNIT AND ACCESSORIES GEH C2 THERAPEUTICS, INC. FG-1012, FG-1009 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other