BEUDAMED
    FDA Adverse Event Death Summary report: N

    C2 CRYOBALLOON ABLATION SYSTEM

    MDR report key: 6404290 · Received March 14, 2017

    Report

    Report Number
    3008780134-2017-00004
    Event Type
    Death
    Date Received
    March 14, 2017
    Date of Event
    February 23, 2017
    Report Date
    March 14, 2017
    Manufacturer
    C2 THERAPETUICS, INC.
    Product Code
    GEH
    UDI-DI
    0854924006
    PMA / PMN Number
    K161202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS ANALYZED AND FOUND TO BE WITHIN SPECIFICATION. PHYSICIAN DETERMINED THAT NO DEVICE MALFUNCTION OCCURRED AND THE EVENT APPEARS TO BE A PROCEDURE-RELATED SAE BUT NOT DEVICE-RELATED.

    Description of Event or Problem · 1

    THE PATIENT HAD WITH A HISTORY BARRETT'S ESOPHAGUS (BE) WITH HIGH GRADE DYSPLASIA EXTENDING FROM 32 CM TO 39 CM, PRAGUE CLASS C4M7, LESIONS OR ESOPHAGITIS, HIATAL HERNIA, AND MULTIPLE PPI-TYPE FUNDLE GLAND TYPE POLYPS IN THE STOMACH. THE C2 CRYOBALLOON ABLATION SYSTEM WAS USED ON 12 SITES WITH A DOSE OF 10 SECONDS BEGINNING AT THE GASTROESOPHAGEAL JUNCTION (GEJ), WHICH WAS CHRONIC. THERE WAS SIGNIFICANT DISTAL BALLOON MIGRATION WITH 6 ABLATIONS AT THE GEJ LIKELY DUE TO PREVIOUS SCARRING FROM CHRONIC GASTROESOPHAGEAL REFLUX DISEASE. THE DISTAL ESOPHAGUS AND THE PROXIMAL BE WITHIN 2 CM OF THE Z LINE WAS TREATED WITH STABLE POSITION AND NO SIGNIFICANT MIGRATION. THERE WAS NO DEVICE MALFUNCTION. PATIENT WAS LATER ADMITTED TO THE MICU FOR HYPOXIA, SEPSIS, AND MULTILOBAR RIGHT LUNG PNEUMONIA BASED ON A CT SCAN. IT WAS CONCLUDED THAT THE PATIENT HAD AN ASPIRATION PNEUMONIA. THE PHYSICIAN COMMUNICATED, "THIS APPEARS TO BE A PROCEDURE-RELATED SAE BUT NOT DEVICE-RELATED." ON (B)(6) 2017, THE PHYSICIAN COMMUNICATED THAT THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186917 C2 CRYOBALLOON ABLATION SYSTEM CRYOSURGICAL UNIT WITH ACCESSORIES GEH C2 THERAPETUICS, INC. FG-1009, FG-1012 10182016-01, 01052017-03 0854924006

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death BOA ENDOSCOPIC VALVE