BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2 CRYOBALLOON ABLATION SYSTEM

    MDR report key: 6170296 · Received December 13, 2016

    Report

    Report Number
    3008780134-2016-00019
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 14, 2016
    Report Date
    December 7, 2016
    Manufacturer
    C2 THERAPEUTICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K131523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. NO FURTHER INVESTIGATION COULD BE PERFORMED. NO DEVICE PERFORMANCE ISSUES WERE REPORTED BY THE USER, AND THE SYSTEM FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED FOR T1A CANCER USING THE CRYOBALLOON ON (B)(6) 2016. THERE WAS NO ADDITIONAL USE OF C2 DEVICE AFTER (B)(6) 2016. A STRICTURE WAS OBSERVED ON (B)(6) 2016. DURING THIS ROUTINE ENDOSCOPY, THE PHYSICIAN INADVERTENTLY CREATED A SLIGHT TEAR IN THE STRICTURE WITH HIS ENDOSCOPE. NO INTERVENTION WAS REQUIRED. THE PATIENT WAS DILATED ON (B)(6) 2016. THE PATIENT REPORTED SLIGHT DYSPHAGIA ON (B)(6), BUT HIS BIOPSY IS NEGATIVE FOR CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821207 C2 CRYOBALLOON ABLATION SYSTEM CRYOSURGICAL UNIT AND ACCESORRIES GEH C2 THERAPEUTICS, INC. FG 1012, FG 1009

    Patients

    Seq Age Sex Outcome Treatment
    1